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To: PGR88

“It shows that Pfizer and Moderna manufacturing and QC for covid vax are still lacking.”

Speaking from 20 years of experience in medical device you must have a qualified, stable manufacturing system in place before a product can even enter clinical trials. And medical device regulatory pathways are not nearly as strict as those for pharmaceuticals.

It would be unheard of that every lot cannot be chemically assayed to ensure lot-to-lot consistency. The Japanese Pharmaceuticals and Medical Devices Agency held up some of the vaccines due to poor QC and (amongst others) lack of biodistribution data.


11 posted on 11/11/2021 2:43:31 PM PST by packagingguy
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To: packagingguy

Tell us more.

Who exactly would be responsible for assuring there is lot to lot consistency?

Would this be done at in-house or contracted out labs?


13 posted on 11/11/2021 2:57:03 PM PST by cgbg (A kleptocracy--if they can keep it. Think of it as the Cantillon Effect in action.)
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